a study to evaluate the effect of asp8597 in adult kidney transplant patients

Conditions: Kidney Transplantation

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of asp8597 in kidney transplant recipients.

this is a two-part study. part 1 (phase 2) has completed enrollment. subjects are currently being followed per protocol. data from part 1 will be used to determine the doses used in part 2 (phase 3). part 2 will enroll approximately 573 subjects and is planned to have 2 doses of asp8597 (low dose and either the high or highest dose) along with placebo.

Eligibility criteria:
inclusion criteria: * subject is scheduled to receive a kidney transplant from a deceased donor meeting at least one of the following criteria: 1. expanded criteria donor (ecd) * i donor was \> 60 years of age, or * ii. donor was 50-59 years of age, inclusive, and met at least two of the following criteria: 1. donor died of a cerebral bleed 2. donor had a history of hypertension 3. donor's terminal serum creatinine concentration was \> 1.5 mg/dl 2. donation after cardiac death (dcd) - donor was pronounced dead prior to procurement of the kidney 3. standard criteria donor (scd) * i. donor with terminal serum creatinine \< 1.5 mg/dl where kidney is anticipated to have a minimum of 24 hours of cold ischemia prior to transplantation, or * ii. donor with terminal serum creatinine \> 1.5 mg/dl and any cold ischemic time up to exclusion limit * female subject is not pregnant and agrees to use an acceptable form of contraception throughout study * male subject agrees to use an adequate method of contraception and agrees to no sperm donation throughout the study exclusion criteria: * female subject is pregnant or lactating * donor kidney is anticipated to have more than 40 hours of cold ischemia time * donor is \> 66 years of age * donor meets both dcd and ecd criteria * subject has previously received, or is receiving an organ transplant other than a kidney * subject has a positive t or b cell crossmatch by the investigational site's standard method of determination. for recipients where only a flow cytometry crossmatch is performed and is positive in either t or b cell testing, recipients are excluded only if donor specific, anti-hla antibody is detected by flow cytometry based, specific anti-hla antibody testing * subject has abo blood type incompatibility with his/her organ donor * recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (hiv) * subject has a known bleeding diathesis * subject has a international normalized ratio (inr) \> 1.5 times upper limit of normal at screening * subject has a platelet count \< 100,000 platelets/µl at screening * subject used anti-platelet agents \[e.g., plavix® (clopidogrel bisulfate), brilinta® (ticagrelor)\] (with the exception of aspirin \< 100 mg/day for cardiovascular prophylaxis), anti-coagulants \[e.g., pradaxa® (dabigatran), xarelto® (rivaroxaban)\], anti-thrombotics, and/or blood-thinning agents within the 10 days prior to screening; and/or subject is expected to require use of any of these agents during the first 15 days of the study period (with the exception of standard of care peri-operative administration of heparin for dvt prophylaxis) * subject has an uncontrolled concomitant infection * subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully * subject currently is participating in an investigational drug study, or participated in an investigational drug study within the last 30 days) * subject has a history of or is believed to have used an illicit drug(s) and/or abused alcohol within the last 3 months * subject has an unstable psychiatric illness * subject has previously received asp8597 or participated in a study involving asp8597

Keywords: de novo kidney transplant kidney transplant asp8597 diannexin ischemia-reperfusion injury